Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
Study NCT ID:
NCT05796557
Status:
COMPLETED
Last Update Posted:
2025-05-31
First Post:
2023-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
ECMO Hemostatic Transfusions in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017713', 'term': 'Platelet Transfusion'}], 'ancestors': [{'id': 'D016913', 'term': 'Blood Component Transfusion'}, {'id': 'D001803', 'term': 'Blood Transfusion'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'oliver.karam@yale.edu', 'phone': '203-785-4651', 'title': 'Oliver Karam', 'organization': 'Yale'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'No limitations or caveats to report.'}}, 'adverseEventsModule': {'timeFrame': 'From randomization up to 24 hours after the end of the intervention, up to 90 days', 'description': 'Serious adverse events, as evaluated by medical monitor.', 'eventGroups': [{'id': 'EG000', 'title': 'Higher Platelet Transfusion Strategy', 'description': 'Participants randomized to this arm will be transfused if the platelet count is \\< 90 x 10e9 cells/L.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 5, 'seriousNumAtRisk': 25, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Lower Platelet Transfusion Strategy', 'description': 'Participants randomized to this arm will be transfused if the platelet count is \\< 50 x 10e9 cells/L.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 5, 'seriousNumAtRisk': 25, 'deathsNumAffected': 2, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Clotting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Accidental Removal of Vascular Access', 'notes': 'Accidental removal of arterial line, requiring replacement.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Clotting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Platelet Transfusion Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Higher Platelet Transfusion Strategy', 'description': 'Participants randomized to this arm will be transfused if the platelet count is \\< 90 x 10e9 cells/L.'}, {'id': 'OG001', 'title': 'Lower Platelet Transfusion Strategy', 'description': 'Participants randomized to this arm will be transfused if the platelet count is \\< 50 x 10e9 cells/L.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '16.6'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to day 21', 'description': "The total dose (in mL/kg/day) will be computed by the research team, by dividing the total platelet transfusion volume by the patient's weight at admission and the number of days of intervention.", 'unitOfMeasure': 'mL/kg/day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Feasibility Assessed by the Screening Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Screened Patients', 'description': 'Number of patients that were screened.'}], 'classes': [{'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At screening', 'description': 'Feasibility will be assessed by the number of eligible participants that were screened.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of eligible patients among the patients that were screened.'}, {'type': 'SECONDARY', 'title': 'Feasibility Assessed by the Inclusion Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Number of Eligible Patients', 'description': 'Number of eligible patients (all inclusion criteria, no exclusion criteria)'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At screening', 'description': 'Feasibility will be assessed by the number of eligible participants that were enrolled.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of eligible patients who were enrolled.'}, {'type': 'SECONDARY', 'title': 'Feasibility Assessed by the Number of Informed Consents Signed in the First 24 Hours Post Cannulation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Approached Patients', 'description': 'Number of approached patients'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At screening', 'description': 'Feasibility will be assessed by the number of participants that sign consent within the first 24 hours after ECMO cannulation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of approached patients who consented.'}, {'type': 'SECONDARY', 'title': 'Compliance With Transfusion Thresholds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}, {'units': 'Transfusion', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Higher Platelet Transfusion Strategy', 'description': 'Participants randomized to this arm will be transfused if the platelet count is \\< 90 x 10e9 cells/L.'}, {'id': 'OG001', 'title': 'Lower Platelet Transfusion Strategy', 'description': 'Participants randomized to this arm will be transfused if the platelet count is \\< 50 x 10e9 cells/L.'}], 'classes': [{'categories': [{'measurements': [{'value': '316', 'groupId': 'OG000'}, {'value': '386', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to Day 21', 'description': 'The proportion of transfusions that were given for platelet counts below the arm threshold will be computed to assess compliance.', 'unitOfMeasure': 'Compliant transfusion', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Transfusion', 'denomUnitsSelected': 'Transfusion', 'populationDescription': 'Number of transfusion decisions (either to transfuse or not to transfuse, based on platelet count).'}, {'type': 'SECONDARY', 'title': 'Participants With at Least One Temporary Suspension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Higher Platelet Transfusion Strategy', 'description': 'Participants randomized to this arm will be transfused if the platelet count is \\< 90 x 10e9 cells/L.'}, {'id': 'OG001', 'title': 'Lower Platelet Transfusion Strategy', 'description': 'Participants randomized to this arm will be transfused if the platelet count is \\< 50 x 10e9 cells/L.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to Day 21', 'description': 'The number of participants who required at least one temporary suspension during ECMO.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration for Temporary Suspensions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Higher Platelet Transfusion Strategy', 'description': 'Participants randomized to this arm will be transfused if the platelet count is \\< 90 x 10e9 cells/L.'}, {'id': 'OG001', 'title': 'Lower Platelet Transfusion Strategy', 'description': 'Participants randomized to this arm will be transfused if the platelet count is \\< 50 x 10e9 cells/L.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '19.6'}, {'value': '13.5', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '23.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to Day 21', 'description': 'The investigators will collect information on the duration of each suspension.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression to Composite Outcome of Severe Bleeding and/or Severe Thrombotic Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Higher Platelet Transfusion Strategy', 'description': 'Participants randomized to this arm will be transfused if the platelet count is \\< 90 x 10e9 cells/L.'}, {'id': 'OG001', 'title': 'Lower Platelet Transfusion Strategy', 'description': 'Participants randomized to this arm will be transfused if the platelet count is \\< 50 x 10e9 cells/L.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to Day 21', 'description': 'The investigators will collect the proportion of participants who progress to a composite outcome of severe bleeding and/or severe thrombosis. The outcome will be adjudicated by an external review committee, blinded to the allocation arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Were Withdrawn and/or Lost to Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Higher Platelet Transfusion Strategy', 'description': 'Participants randomized to this arm will be transfused if the platelet count is \\< 90 x 10e9 cells/L.'}, {'id': 'OG001', 'title': 'Lower Platelet Transfusion Strategy', 'description': 'Participants randomized to this arm will be transfused if the platelet count is \\< 50 x 10e9 cells/L.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 90 days', 'description': 'Number of patients who withdraw from the study and/or are lost to follow-up (i.e., withdraw and/or are missing 90-day mortality assessment)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pre-transfusion Platelet Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Higher Platelet Transfusion Strategy', 'description': 'Participants randomized to this arm will be transfused if the platelet count is \\< 90 x 10e9 cells/L.'}, {'id': 'OG001', 'title': 'Lower Platelet Transfusion Strategy', 'description': 'Participants randomized to this arm will be transfused if the platelet count is \\< 50 x 10e9 cells/L.'}], 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '86'}, {'value': '43', 'groupId': 'OG001', 'lowerLimit': '39', 'upperLimit': '47'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During intervention', 'description': 'Pre-transfusion platelet count, during intervention', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Higher Platelet Transfusion Strategy', 'description': 'Participants randomized to this arm will be transfused if the platelet count is \\< 90 x 10e9 cells/L.'}, {'id': 'FG001', 'title': 'Lower Platelet Transfusion Strategy', 'description': 'Participants randomized to this arm will be transfused if the platelet count is \\< 50 x 10e9 cells/L.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Higher Platelet Transfusion Strategy', 'description': 'Participants randomized to this arm will be transfused if the platelet count is \\< 90 x 10e9 cells/L.'}, {'id': 'BG001', 'title': 'Lower Platelet Transfusion Strategy', 'description': 'Participants randomized to this arm will be transfused if the platelet count is \\< 50 x 10e9 cells/L.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0.8'}, {'value': '0.2', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '3.2'}, {'value': '0.2', 'groupId': 'BG002', 'lowerLimit': '0.0', 'upperLimit': '1.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cannulation Type', 'classes': [{'categories': [{'title': 'Veno-venous', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Veno-arterial', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-15', 'size': 2181984, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-17T17:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Investigators and Outcome Assessors will be masked to the intervention, but the clinical team at the bedside will need to know the allocation to be able to prescribe platelet transfusion according to the randomized threshold.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomized in a 1:1 ratio to either arm. Subjects will be stratified by type of extracorporeal membrane oxygenation (ECMO) support (Veno-Arterial vs Veno-Venous), by site, and by age (≤28 days vs \\>28 days).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-30', 'studyFirstSubmitDate': '2023-03-17', 'resultsFirstSubmitDate': '2025-04-21', 'studyFirstSubmitQcDate': '2023-03-30', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-30', 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Platelet Transfusion Dose', 'timeFrame': 'up to day 21', 'description': "The total dose (in mL/kg/day) will be computed by the research team, by dividing the total platelet transfusion volume by the patient's weight at admission and the number of days of intervention."}, {'measure': 'Pre-transfusion Platelet Count', 'timeFrame': 'During intervention', 'description': 'Pre-transfusion platelet count, during intervention'}], 'secondaryOutcomes': [{'measure': 'Feasibility Assessed by the Screening Rate', 'timeFrame': 'At screening', 'description': 'Feasibility will be assessed by the number of eligible participants that were screened.'}, {'measure': 'Feasibility Assessed by the Inclusion Rate', 'timeFrame': 'At screening', 'description': 'Feasibility will be assessed by the number of eligible participants that were enrolled.'}, {'measure': 'Feasibility Assessed by the Number of Informed Consents Signed in the First 24 Hours Post Cannulation.', 'timeFrame': 'At screening', 'description': 'Feasibility will be assessed by the number of participants that sign consent within the first 24 hours after ECMO cannulation.'}, {'measure': 'Compliance With Transfusion Thresholds', 'timeFrame': 'up to Day 21', 'description': 'The proportion of transfusions that were given for platelet counts below the arm threshold will be computed to assess compliance.'}, {'measure': 'Participants With at Least One Temporary Suspension', 'timeFrame': 'up to Day 21', 'description': 'The number of participants who required at least one temporary suspension during ECMO.'}, {'measure': 'Duration for Temporary Suspensions', 'timeFrame': 'up to Day 21', 'description': 'The investigators will collect information on the duration of each suspension.'}, {'measure': 'Progression to Composite Outcome of Severe Bleeding and/or Severe Thrombotic Event', 'timeFrame': 'up to Day 21', 'description': 'The investigators will collect the proportion of participants who progress to a composite outcome of severe bleeding and/or severe thrombosis. The outcome will be adjudicated by an external review committee, blinded to the allocation arm.'}, {'measure': 'Number of Participants Who Were Withdrawn and/or Lost to Follow-up', 'timeFrame': 'Up to 90 days', 'description': 'Number of patients who withdraw from the study and/or are lost to follow-up (i.e., withdraw and/or are missing 90-day mortality assessment)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Platelet transfusion', 'ECMO', 'Bleeding', 'Clotting', 'Mortality'], 'conditions': ['Extracorporeal Membrane Oxygenation Complication', 'Hemorrhage', 'Thromboembolism', 'Transfusion Adverse Reaction']}, 'descriptionModule': {'briefSummary': 'Critically ill children supported by extracorporeal membrane oxygenation (ECMO) receive large volumes of prophylactic platelet transfusions to prevent bleeding. However, mounting evidence has demonstrated significant morbidity and mortality associated with these transfusions. The ECmo hemoSTAtic Transfusions In Children (ECSTATIC) pilot trial will test two different platelet transfusion strategies, based on two different platelet counts thresholds, one high (higher platelet transfusion strategy) and one low (lower platelet transfusion strategy). The pilot will gather the necessary information to perform a full trial which will provide a better understanding of how to transfuse platelets to children supported by ECMO and reduce the associated morbidity.', 'detailedDescription': "Due to coagulopathy and thrombocytopenia induced by hemodilution and the extracorporeal circuit itself, children supported by extracorporeal membrane oxygenation (ECMO) are at significant risk of bleeding. In order to prevent bleeding, pediatric intensivists often prescribe prophylactic platelet transfusions. However, in observational studies, prophylactic platelet transfusions to children on ECMO have been independently associated with increased thrombosis, mortality, and paradoxically, increased bleeding. Guidelines to direct platelet transfusions in this patient population are limited by the lack of evidence and therefore based on expert opinion alone. Given the significant associated risks, it is crucial to provide evidence to guide clinicians.\n\nThe ECSTATIC pilot, a randomized controlled trial endorsed by BloodNet, PediECMO, the Extracorporeal Life Support Organization (ELSO), and the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI), will be conducted in ten sites (9 in the US and 1 in Israel). The investigators will enroll an anticipated 50 consecutive critically ill children (0 to \\<18 years of age), admitted to a participating pediatric, neonatal, or cardiac intensive care unit (PICU/NICU/CICU), on ECMO, and who have either no bleeding or minimal bleeding.\n\nNon-bleeding children 0 to less than 18 years of age will be randomized 1:1 to either a platelet transfusion threshold of 90 x10e9/L (higher platelet transfusion strategy) or 50 x10e9/L (lower platelet transfusion strategy). Participants will be followed until progression to severe bleeding and/or severe thrombosis, decannulation from ECMO, or reach 21 days.\n\nIn this pilot, the investigators will test the separation between the lower and higher transfusion strategies. The primary outcomes will be the separation between pre-transfusion platelet counts, and the total platelet dose (in mL/kg/run). Secondary outcomes will be feasibility of patient enrollment and ability for an adjudication committee to determine the severity of bleeding and thrombotic outcomes.\n\nThe purpose of this pilot study is to determine the feasibility of the transfusion strategies, intervention parameters, subject availability, and other information regarding outcomes that are essential to complete the design of a large randomized controlled trial.\n\nThe large future trial will evaluate the efficacy of the two transfusion strategies, in terms of progression to severe bleeding and/or severe thrombosis. To adequately calculate the sample size, the investigators need to know the difference between the pre-transfusion platelet counts, the screening and inclusion rates, the proportion of patients who are consented within the first 24 hours after cannulation, the proportion of transfusions that are compliant with each arm's strategy, and the number of temporary suspensions.\n\nThe proposed pilot trial is innovative in that it is focused on children supported by ECMO, a population in whom transfusion strategies have never been tested previously; it involves the largest separation between the two arms of any platelet transfusion trial conducted in the past; and it involves two newly developed definitions of bleeding and thrombosis particularly applicable to children supported by ECMO.\n\nThe pilot trial will provide necessary and sufficient information to proceed with the definitive ECSTATIC Randomized Controlled Trial (RCT) to evaluate the impact of a lower prophylactic platelet transfusion threshold on the clinical outcomes in children on ECMO. ECSTATIC has the potential to optimize efficacy, to reduce platelet transfusion exposure and to decrease mortality and morbidity of these extremely ill infants and children."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Critically ill children (0 to \\<18 years of age)\n* Admitted to a participating pediatric, neonatal, or cardiac intensive care unite (PICU/NICU/CICU)\n* On extracorporeal Membrane Oxygenation (ECMO)\n* Who have either no bleeding or minimal bleeding, within 24 hours of cannulation. Minimal bleeding is defined as:\n\n * streaks of blood in endotracheal tube or during suctioning only\n * streaks of blood in nasogastric tube\n * macroscopic hematuria\n * subcutaneous bleeding (including hematoma and petechiae) \\< 5 cm in diameter\n * quantifiable bleeding \\< 1mL/kg/hr (e.g., chest tube)\n * bloody dressings required to be changed no more often than each 6hr, or weighing no more than 1mL/kg/hr if weighed, due to slow saturation\n\nExclusion Criteria:\n\n* Post-conception age \\< 37 weeks at time of screening\n* Underlying oncologic diagnosis (defined as receipt of chemotherapy or radiation in the last six months) or recipient of bone marrow transplant in the last year\n* Congenital bleeding disorder\n* Pregnant or admitted post-partum\n* Decision to withdraw or withhold some critical care or interventions\n* Known objection to blood transfusions\n* On ECMO for \\> 24 hours at time of enrollment'}, 'identificationModule': {'nctId': 'NCT05796557', 'acronym': 'ECSTATIC', 'briefTitle': 'ECMO Hemostatic Transfusions in Children', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'ECMO Hemostatic Transfusions in Children', 'orgStudyIdInfo': {'id': '2000034604'}, 'secondaryIdInfos': [{'id': '1R34HL159119-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R34HL159119-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Higher platelet transfusion strategy', 'description': 'Participants randomized to this arm will be transfused if the platelet count is \\< 90 x 10e9 cells/L.', 'interventionNames': ['Biological: Platelet Transfusion']}, {'type': 'EXPERIMENTAL', 'label': 'Lower platelet transfusion strategy', 'description': 'Participants randomized to this arm will be transfused if the platelet count is \\< 50 x 10e9 cells/L.', 'interventionNames': ['Biological: Platelet Transfusion']}], 'interventions': [{'name': 'Platelet Transfusion', 'type': 'BIOLOGICAL', 'description': 'Participants will be transfused according to the assigned threshold for each group, with a transfusion dose of 10 mL/kg, up to one adult unit.', 'armGroupLabels': ['Higher platelet transfusion strategy', 'Lower platelet transfusion strategy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta - Emory", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Health Care', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': "Norton Children's Hospital", 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Morgan Stanley Children's Hospital of New York Presbyterian", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Komansky Children's Hospital of New York Presbyterian", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': "Golisano Children's Hospital", 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University School of Medicine', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '23219', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': "Children's Hospital of Richmond at VCU", 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Children's Hospital of Wisconsin", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '49504', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': "Schneider Children's Medical Center", 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'overallOfficials': [{'name': 'Oliver Karam, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}, {'name': 'Marianne Nellis, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NewYork-Presbyterian / Weill Cornell'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': "The investigators reserve the right to embargo the data for as long as two years after completion of the project (i.e. fall 2027) in order to allow the investigators' research team to publish additional observations from the data.", 'ipdSharing': 'YES', 'description': "The proposed research will include data from 50 critically ill subjects who are on extracorporeal life support (ECMO) enrolled at ten participating sites. The final dataset will include demographic and medical information, as well as laboratory data.\n\nAfter the investigators' proposed research is complete, each participating site will destroy the key linking this data to protected health information (PHI). Thus, the data will then be completely de-identified. However, the investigators believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics, considering the variety of rare conditions leading to ECMO.", 'accessCriteria': 'The investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying the data after analyses are completed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, {'name': 'University of Utah', 'class': 'OTHER'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Columbia University', 'class': 'OTHER'}, {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, {'name': 'University of Rochester', 'class': 'OTHER'}, {'name': "Children's Hospital and Health System Foundation, Wisconsin", 'class': 'OTHER'}, {'name': 'Duke University', 'class': 'OTHER'}, {'name': "Johns Hopkins All Children's Hospital", 'class': 'OTHER'}, {'name': 'University of Iowa', 'class': 'OTHER'}, {'name': 'Emory University', 'class': 'OTHER'}, {'name': "Schneider Medical Children's Center, Israel", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}